Findings
1Laboratory and QC controls
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You released finished OTC drug products based on release testing performed by a third-party contract testing laboratory (CTL). The analytical test methods had not been validated for accuracy, specificity, and reproducibility. For example, the zinc oxide release test method that your CTL used was validated for another customer’s…
2Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your investigations were inadequate. You implemented ineffective corrective actions and preventive actions as you repeatedly obtained OOS viscosity and high water activity results. During an approximately two-year time period, you recorded at least 25…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm distributed various over-the-counter (OTC) drug products, but you failed to adequately validate your drug manufacturing processes and lacked adequate process validation studies for multiple products. In…
About this record
Extracted automatically from the document US FDA published on 2022-05-03. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
